PRC Guidelines for Initial Submission
Therapeutic and Interventional Studies
Requires Full Committee Review unless otherwise determined
- Final protocol (not the HIC application)
- Investigator’s Brochure (as applicable)
- A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - click to download
Non-Therapeutic Studies
Requires administrative review conducted by the Office of Quality Assurance and Training unless otherwise determined
- Protocol (if separate document from the HIC application)
- HIC Application
- A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - click to download
National Clinical Trials Network Studies
Requires review by PRC chair or vice chair unless otherwise determined
- Final protocol
- Investigator’s Brochure (as applicable)
- A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - click to download